RITUXAN+CHEMO significantly prolonged OS in younger DLBCL patients
MInT TRIAL DESIGN: R-CHEMO ×6 VS CHEMO ×61
- CHEMO=CHOP every 3 weeks, CHOEP (CHOP+etoposide) every 3 weeks, MACOP-B (methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin) biweekly, or PMitCEBO (prednisolone, mitoxantrone, cyclophosphamide, etoposide, bleomycin, and vincristine) biweekly. R=RITUXAN 375 mg/m2 every 3 weeks for 6 cycles, beginning on the first day of chemotherapy.2
- MInT=MabThera® (Rituximab) International Trial; OS=overall survival; DLBCL=diffuse large B-cell lymphoma; IPI=International Prognostic Index; CHOP=cyclophosphamide, doxorubicin, vincristine, and prednisone.
MInT: YOUNGER, LOW-RISK DLBCL PATIENTS1
|Baseline patient characteristics||
|Age range (years)||18-60||18-60|
|Elevated LDH (>1×ULN)||30%||29%|
|Ann Arbor Stage||I/II III/IV||
|ECOG performance status||0-1 2-3||
|Bulky disease (>10 cm)||50%||48%|
|Extranodal involvement (≥2)||33%||35%|
|IPI score*||<2 ≥2||
- *In the MInT trial of younger adults, an age-adjusted IPI was used, which ranged from 0 to 3 and was derived by assigning 1 point for each of the following risk factors: Ann Arbor Stage III or IV, ECOG performance status ≥2, and elevated LDH. Per the protocol, patients were to have an IPI score of <2.
- LDH=lactate dehydrogenase; ULN=upper limit of normal; ECOG=Eastern Cooperative Oncology Group.
R-CHEMO provided a significant overall survival advantage in DLBCL
- 2-year OS was 95% for R-CHEMO vs 86% for CHEMO alone (p<0.05)3
- Median of primary endpoint of time to treatment failure not reliably estimated (55% risk reduction, p<0.05)30.05)
RITUXAN in combination with CHOP chemotherapy for DLBCL
- Detailed safety data collection was primarily limited to Grade 3 and 4 adverse reactions and serious reactions. In studies of elderly patients with DLBCL, the following adverse reactions, regardless of severity, were reported more frequently (≥5%) in patients ≥60 years of age receiving R-CHOP as compared with CHOP alone: pyrexia (56% vs. 46%), lung disorder (31% vs. 24%), cardiac disorder (29% vs. 21%), and chills (13% vs. 4%)
- A review of cardiac toxicity determined that supraventricular arrhythmias or tachycardia accounted for most of the difference in cardiac disorders (4.5% for R-CHOP vs. 1.0% for CHOP)
- The following Grade 3 or 4 adverse reactions occurred more frequently among patients in the R-CHOP arm compared with those in the CHOP arm: thrombocytopenia (9% vs. 7%) and lung disorder (6% vs. 3%). Other Grade 3 or 4 adverse reactions reported more frequently among patients receiving R-CHOP were viral infection, neutropenia, and anemia
- Data on file, Genentech, Inc.
- Pfreundschuh M, Trümper L, Österborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large-B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol. 2006;7:379-391.
- RITUXAN® (Rituximab) full prescribing information, Genentech, Inc., 2014.